Package Validation

 

Situation: "What are the steps necessary in a package validation to comply with the FDA requirements?"



Solution:
LSO will evaluate your product/package, write the validation protocol, specify sample requirements, provide complete testing services using its in-house ISTA certified test laboratory and issue a final report ready for submission to the appropriate regulatory body. LSO can also perform tests designed to determine if your package design is adequate BEFORE the validation process is started.

In-house capabilities include:

  • Shelf-life studies/accelerated aging: Elevated temperature and humidity as well as freezing
  • Transportation/distribution simulation: Vibration, compression and drop testing
  • Package seal strength: Peel, burst, creep and visual inspection
  • Package integrity: Dye penetration or bubble emission
© 2006 Life Science Outsourcing Inc.